Encompass

Basic Information

• Brand Name: Encompass
• Primary DI: 10612899000381
• Version / Model: 46150-035
• Company Name: Encompass Group, L.L.C.
• Labeler DUNS: 121788819
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 300
• Record Status: Published
• Publish Date: 2022-08-12
• Public Version: 2
• Public Version Date: 2023-05-05
• Public Version Status: Update
• Public Device Record Key: b303ea06-3f40-4bc7-8e81-1f39a11aba3c

Device Description

INFANT SHIRT, NB, 300EA TS INFANT SHIRT, LONG SLV, PRINT, PET, 25/BG, 12 BG/CS NW

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FME	Gown, Examination	General Hospital	880.6265	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35092	Patient gown, single-use	A non-sterile garment made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and may be closed by ties at the back/side of the garment. This is a single-use garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10612899000381	GS1
Unit of Use	30612899000385	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]